ETEC Notice of Intent to Sole Source.docx

Notice of Intent to Sole Source

The United States Army Medical Research Acquisitions Activity (USAMRAA), on behalf of the United States Army Medical Materiel Development Activity (USAMMDA), is issuing this Notice of Intent to Modify an Existing Contract within Scope. This is not a request for proposals. This notice does not represent a commitment by the government to pay for costs incurred from the preparation and/or submission of data in response to this notice.

The Government has a requirement for the continuing effort for development of a Phase 2 Clinical cGMP manufactured product of quantity and quality that it is suitable and appropriate for use in pivotal clinical studies to demonstrate efficacy against Enterotoxigenic Escherichia coli (ETEC) in adults with the goal of FDA licensure. The objective activities will support a multivalent ETEC vaccine with the long-term goal of preventing bacterial diarrhea in Warfighters.

Through extensive market research, Scandinavian Biopharma was identified for its advanced development of a multivalent ETEC vaccine for adult traveler indication. There is currently no such vaccine on the market; prevention is achieved through sanitation and hygiene and treatment is through antibiotic administration. Passive immune supplements consisting of bovine colostrum antibodies against ETEC are available but must be taken prior to every meal or other food/drink consumption to be effective. These limitations have created a gap in Warfighter infectious disease prevention and market research has determined Etvax, the vaccine under development by Scandinavian Biopharma, possesses the following characteristics which, taken together, address the requirements to fill that gap and provide the highest technology readiness level of any other product under development:

1) The vaccine has been shown to be safe in humans (adults and children). The first generation of the vaccine has shown to be 60-80% effective against diarrhea caused by ETEC.

2) The second generation vaccine improves the multivalent composition of the first generation vaccine, with five antigenic components (up to 90% ETEC strain coverage) and the addition of an adjuvant.

3) The vaccine has shown stability for 5 years.

4) The vaccine is administered in 2 oral doses.

Moreover, Scandinavian Biopharma has achieved clinical progress which contributes to a TRL6 technology readiness level. They have completed a Phase I/II clinical trial with their first generation vaccine under a U.S. IND using an adult traveler population exposed to ETEC under natural transmission conditions. Using second generation Etvax, they have already demonstrated safety and significant immunogenicity in adults and have completed the active portion of a Phase IIb study using adult Finnish travelers to a high transmission area.

Contract Modification W81XWH-20-C-0137-P00006 will be issued on a sole source basis. The North American Industry Classification System (NAICS) code for this requirement is 325412 and the size standard is 1,250 employees. Any sources that believe they are eligible to provide these services must respond in writing. Responses must be supported with clear and convincing evidence articulating the ability to provide the items outlined above. A request for documentation will not be considered an affirmative response. Information received will be considered solely for the purposes of determining whether a competitive procurement is in the best interest of the Government. If no written responses are received by the date listed below, which reflects fifteen (15) days after the publication of this notice, a contract modification will be awarded without further remark.

This notice is provided solely as information to the marketplace.

CONTACT INFORMATION: Questions may be submitted to Timothy Kelly at timothy.j.kelly169.civ@health.mil no later than 3:00PM Eastern Time on Wednesday, 28 August 2024.